Prevalence and Clinical Spectrum of the 22q11 Deletion

Tracking Information
First Submitted Date	December 19, 2005
First Posted Date	December 21, 2005
Last Update Posted Date	May 4, 2007
Study Start Date	January 1967
Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00267397 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Prevalence and Clinical Spectrum of the 22q11 Deletion
Official Title	Prevalence and Clincial Spectrum of the 22q11 Deletion: A Population Based Study of Children and Congenital Heart Defects
Brief Summary	The purpose of this project is to conduct population based surveillance for prenatally diagnosed congenital defects amount residents of the five counties to: improve the comprehensiveness of the Metropolitan Atlanta Congenital Defects Program (MACDP) to (1) better fulfill its objectives (2) allow assessment of the impact of prenatal diagnosis and elective termination on the birth prevalence of congenital defects in Atlanta (3) develop a registry of prenatally diagnosed defects to be used in epidemiologic and genetic studies, in evaluation prevention programs and in monitoring prenatal diagnostic technology.
Detailed Description	Since 1967, The Centers for Disease Control and Prevention (CDC) has conducted surveillance of birth defects in metropolitan Atlanta through review of hospital delivery and newborn medical records and records from various other medical sources in the five central counties of the metropolitan area (Clayton, Cobb, DeKalk, Fulton and Gwinnett, and has been expanded to include prenatal records. The project was begun n the aftermath of thalidomide and rubella epidemics as a kind of early-warning system for new or resurgent teratogens. The voluntary participation of Atlanta hospitals was sought and obtained at the inception of the system (the original system was a joint effort of the CDC, the Georgia Institute of Mental Health and Emory University). A case must be diagnosed by the child's sixth birthday or within six years of the date of elective termination. Children's Healthcare is one retrospective source of medical records reviewed for discharge summaries and disease indices.
Study Type	Observational
Study Design	Observational Model: Defined Population; Observational Model: Natural History; Time Perspective: Longitudinal; Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Not Provided
Study Population	Not Provided
Condition	Congenital Disorders
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Terminated
Enrollment	Not Provided
Original Enrollment	Not Provided
Study Completion Date	December 2006
Primary Completion Date	Not Provided
Eligibility Criteria	Inclusion Criteria: birth defect diagnosed by the child's sixth birthday; birth defect diagnosed within 6 years of the elective date of termination Exclusion Criteria: those who do not meet inclusion criteria
Sex/Gender	Sexes Eligible for Study: All
Ages	up to 6 Years (Child)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	United States
Removed Location Countries
Administrative Information
NCT Number	NCT00267397
Other Study ID Numbers	01-107
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	Not Provided
Study Sponsor	Children's Healthcare of Atlanta
Collaborators	Not Provided
Investigators	Principal Investigator: Robert M. Campbell, MD Children's Healthcare of Atlanta
PRS Account	Children's Healthcare of Atlanta
Verification Date	May 2007